Pharmaceutical Reform: A Guide to Improving Performance and Equity

Description

This book applies an established analytical framework for health sector reform (Getting Health Reform Right, Oxford, 2004) to the performance problems of the pharmaceutical sector. The book is divided into three sections. The first section presents the basic ideas for analysis. It begins by insisting that reform start with a clear understanding of the performance deficiencies of the current system. Like all priority setting in the public sector, this 'definition of the problem' involves both ethical choices and political processes. Early chapters explain the foundations of these ideas and apply them to the pharmaceutical sector. The relationship of ultimate outcomes (like health status or risk protection) to classic health systems concepts like efficiency, access and quality is also explored. The last chapter in the first part is devoted to 'diagnosis'―explaining how to move from the definition of a problem to an understanding of how the functioning of the system produces the undesirable outcomes in question. The second part of the book devotes one chapter to each of five 'control knobs': finance, payment, organization, regulation and persuasion. These are sets of potential interventions that governments can use to improve pharmaceutical sector performance. Each chapter presents basic concepts and discusses examples of reform options. Throughout we provide 'conditional guidance'―avoiding the approach of a 'one size fits all' model of 'best practices' in these five arenas for reform. Instead we stress the need for local knowledge of political systems, administrative capacities, community values and market conditions in order to design pharmaceutical sector policies appropriate to a country’s particular circumstances. The last part of the book is a set of teaching cases. Each is preceded by questions and is followed by a brief note on the lessons to be learned. The goal is to help readers develop the skills they need to deal effectively with pharmaceutical sector reform problems in their own countries. Contents Foreword Preface Acknowledgments Chapter 1. Introduction Why Care about Pharmaceutical Policy? What Is Pharmaceutical Policy? What the Book Seeks to Accomplish References Chapter 2. Using the Flagship Framework to Reform Pharmaceutical Policy How to Begin the Process of Reform Ultimate Performance Goals The Role of Cost in Setting Reform Goals The Role of Politics and Ethics in Identifying Problems and Choosing Reform Priorities The Reform Cycle The Control Knobs Government Failures and Market Failures Summary on the Flagship Framework References Chapter 3. Introduction to the Pharmaceutical Sector The World Pharmaceutical Market Consolidation of Research and Development Companies Pharmaceutical Pricing The Role of National Policy Summary on the Pharmaceutical Sector References Chapter 4. Ethics and Priority Setting in Pharmaceutical Reform Commonly Identified Pharmaceutical Sector Problems Relating Identified Problems to Performance Goals Relating Performance Goals to Ethical Perspectives: Utilitarianism Relating Performance Goals to Ethical Perspectives: Liberalism Relating Performance Goals to Ethical Perspectives: Communitarianism The Flagship Framework and Economic Development Goals The International Dimension of Pharmaceutical Policy The Importance of Fair Process Summary on Ethics (and Some Suggestions) Case Studies for Chapter 4 (Ethics) References Chapter 5. Diagnosing Performance Problems and Developing a Policy Response A Simple Pharmaceutical Example to Illustrate the Method The Intermediate Performance Goals and Their Role in the Diagnostic Process Using the Intermediate Performance Measures A Systems Approach to Process Improvement Developing Policy Responses Summary on Diagnosis References Chapter 6. Managing the Politics of Pharmaceutical Policy Reform The Role of Politics in Pharmaceutical Policy Making Stakeholder Analysis and Political Context Moving to Strategy Development The Politics of Pharmaceutical Policy Reform—Some Examples Summary on Politics Case Study on Politics References Chapter 7. Financing the Pharmaceutical Sector Pharmaceutical Financing and Health Sector Financing Judging the Distributional Impact of Financing Options Pharmaceutical Financing Choices Summary on Financing Case Study on Financing and Payment References Chapter 8. Paying for Pharmaceuticals Pharmaceutical Payment Reform and Health Sector Reform Pharmaceutical Payment and Corruption Procurement Wholesale Payments Payments by End Users Summary on Payment Case Studies on Financing and Payment References Chapter 9. Organizing the Public Sector to Improve Pharmaceutical Performance Pharmaceutical Sector Performance: The Six Keys Autonomy, Corporatization, and Marketization Contracting In and Contracting Out Decentralization Social Franchising Using the New Public Sector Management Essential Medicines Lists The Potential Contribution of Process Improvement The Challenges of Change Summary on Organization Case Studies on Organization References Chapter 10. Improving Pharmaceutical Sector Performance through Regulation The Conditions for Successful Regulation Regulating Product Quality Regulating Use Regulation Directed at Controlling Prices Summary on Regulation Case Studies on Regulation References Chapter 11. Using Persuasion to Influence Pharmaceutical Use Elements of Human Decision Making Using Persuasion: The Lessons of Social Marketing Changing Behavior in the Pharmaceutical Sector Summary on Persuasion Case Studies on Persuasion References Chapter 12. Conclusions Thinking about Pharmaceutical Systems Steps in the Process Final Thoughts Case Study A. Defining an Essential Medicines List in Sudamerica Case Study B. Registering Misoprostol in Sri Lanka Case Study C. Disentangling Prescribing and Dispensing in the Republic of Korea Case Study D. Last Mile Logistics for Essential Drugs: The Case of Zambia Case Study E. Drug Procurement in East Africania Case Study F. Converting Basic Drug Shops to Accredited Drug Dispensing Outlets in Tanzania Case Study G. Counterfeit Medicines in Nigeria Case Study H. Changing the Use of Antibiotics in Peru Case Study I. Preparing for Microbicide Introduction in South Africa Case Study J. Drug Coverage in Ghana’s National Health Insurance Scheme Index Figures 1.1 The Pharmaceutical System 2.1 The Flagship Framework for Health System Performance 2.2 Cost-Performance Trade-Offs 2.3 The Reform Cycle 3.1 Growth Forecasts for Global Pharmaceutical Sales by Region 3.2 Distribution of Population and Total Pharmaceutical Expenditure by Country Income Level, 2005–06 3.3 Medicines in Countries’ International Trade, Exports minus Imports, 2009 3.4 Evolution of the Pharmaceutical Sector in Countries of Different Income Levels 4.1 The Relationship of Pharmaceutical Sector Problems to Ultimate Performance Goals 5.1 Pharmaceutical Performance Diagnostic Tree 5.2 Schematic Overview of the Determinants of System Performance 5.3 The Effect of Alternative Quality Improvement Strategies: The “Rotten Apple” View 5.4 The Effect of Alternative Quality Improvement Strategies: The Systems View 7.1 National Health Insurance Coverage for Countries by Region 7.2 Commodity Logistics System in Kenya 8.1 Private Sector Patient Prices for Selected Medicines in Pakistan Compared to International Reference Prices 9.1 The Six Keys to Organizational Performance 10.1 The Regulatory Cycle D1 Current Public Health Sector Distribution System D2 Unfilled Posts in the Health Sector F1 Tiers of Drug Retailers F2 Accredited Drug Dispensing Outlet Program Outline J1 Drug Costs as a Proportion of Total National Health Insurance Claims Costs J2 Regional Analysis of National Health Insurance Per Capita Costs and Participation Rates Tables 1.1 Top 10 Causes of Death by Income Group, 2004 1.2 Pharmaceutical Expenditures by Country Income Level, 2006 3.1 R&D Expenditures by Government and the Pharmaceutical Industry in Selected High-Income Countries, 2008 3.2 Top 10 Pharmaceutical Importing Countries in Africa, 1998 4.1 Summary of Three Ethical Views 7.1 Resources for Medicines and Medical Supplies in Liberia, 2007 and 2008 7.2 Pharmaceutical Financing: Comparing Options 8.1 Cumulative Percentage Markups in the Public and Private Sectors in 11 Countries 8.2 Affordability of Selected Medicines in the Middle East and North Africa 9.1 Limited Human Resources in Low-Income and Other Selected Countries D1 Health Facilities D2 Supply Chain Improvement Alternatives J1 Top 100 Drugs in the National Health Insurance Scheme by Cost and Utilization J2 Sources of Funding for Prescription Drug Purchases in 2008